Collapsible ampoules



Sept. 12,1967 A, BANE 3,340,869

COLLAPS IBLE AMPOULES Filed July 20. 1964 United States Patent 3,340,869COLLAPSIBLE AMPOULES Arthur Bane, 25 Thurloe Court, Fulham Road, LondonS.W. 3, England Filed July 20, 1964, Ser. No. 383,777 Claims priority,application Great Britain, Aug. 8, 1963, 31,426/63; Dec. 16, 1963,49,677/63 7 Claims. (Cl. 1282) The present invention relates to anampoule in the form of a transparent, or translucent concertina-typecollapsible bellows and which is provided or adapted to be provided atone end with a hypodermic needle so as to form a surgical hypodermicsyringe and is also concerned with surgical hypodermic syringesembodying ampoules of this character.

One object of this invention is to provide an inexpensive, expendableampoule which, having been pre-filled with a predetermined quantity of amedium to be injected and embodied in a hypodermic syringe, can beoperated, after insertion of the hypodermic needle into a patient butprior to injection of its contents, to indicate whether the needle haspunctured a blood vessel and should therefore be withdrawn andreinserted in a different position and/ or direction.

A further object is to provide an ampoule which is particularly welladapted for use in conjunction with a hypodermic needle for takingsamples of body fluids.

With these objects in view, the concertina-type bellows of the ampouleaccording to this invention has two parts. One of these parts, whichconsists of one or more sections of the bellows, is designed to containa predetermined quantity of a liquid medicament which will eventually beinjected into the patient. The other part, which consists of at leastone further bellows section, is designed to be used primarily fortesting, after the hypo dermic needle has been inserted into thepatients body but prior to injection of the liquid medicament, whetherthe hypodermic needle has been correctly inserted, i.e. whether it hasor has not penetrated into a blood vessel to enable such testing to becarried out reliably and safely, one wall of the or each further bellowssection is const-r-ucted so that firstly it has less structuralstiffness against deformation under axial compression than the other endwall of the same bellows section, secondly it is collapsible under apredetermined axial compression force into an inverted fully collapsedposition in which it lies close against the inner surface of the otherend wall of the same bellows section and thirdly it has an inherentover-center bias which provides yielding resistance to initialdisplacement thereof out of the said inverted fully collapsed positionin the direction to expand the bellows section of which it forms part.

In use, the said other part of the bellows is collapsed before thehypodermic needle is inserted into the patients body. During insertionof the needle, it remains in a stable collapsed condition due to itssaid inherent over-center bias. Next, in order to test whether theneedle has been correctly inserted, the said one wall of the or eachfurther bellows section constituting the said other part of the bellowsis pulled out away from the other end wall thereof so as to applysuction through the hypodermic needle. If the needle has penetrated intoa blood vessel, blood will be drawn by this suction into the ampoule andwill be visible to the user through the translucent material thereof. Ifthe needle has not penetrated into a blood vessel,

the user will observe that no blood has been drawn in. If this testshows that the needle has been incorrectly inserted, the needle must bewithdrawn and reinserted at a different injection site where the test isagain carried out. This procedure is repeated, if necessary, until theneedle is shown to have been correctly inserted, whereupon the userapplies sufiicient compression force to the ampoule to collapse all thebellows section, so that the liquid medicament will be dischargedthrough the needle into the patients body.

The invention will now be described by way of example with reference tothe accompanying drawings, in which:

FIG. 1 is a partly sectioned side view of a surgical hypodermic syringeembodying an ampoule which is shown in the fully expanded condition,

FIG. 2 is a fragmentary view of the ampoule of the same syringe with onebellows section collapsed,

FIG. 3 is a view corresponding to FIG. 1 of an alternative form ofsyringe ampoule, and

FIG. 4 is a partly sectioned side view of a sealed ampoule.

In FIG. 1 of the drawings, a needle unit, consisting of a hollow needle1 fixed in a needle carrier 2, is shown engaged as a friction fit overthe tapered end of a nozzle 3 on one end of a bellows-type ampoule 4.Integrally formed on the other end of the ampoule 4 is a stud 5 havinga. neck 7 and a head 8.

The end section 9, 10 of the ampoule bellows is of larger diameter thanthe remaining bellows sections 11 and consequently is independentlycollapsible by applying against the end surface 12 of the stud 5 anaxial force which is smaller than that required to collapse the saidremaining bellows sections. Furthermore, the end section 9, 10 is soconstructed and arranged that, under this smaller axial force, the wall9 of the end section is resiliently deformed from the position shown inFIG. 1, past a dead-center position (not shown) into the collapsedposition shown in FIG. 2 in which it lies in close contact against theinner surface of the wall 10. The wall 10 is structurally stiffer thanthe wall 9 and undergoes relatively little deformation during thecollapse of the end section 9, 10.

To restore the end section to the expanded condition shown in FIG. 1,the user must pull the stud 5 in the direction away from the needle 1until the wall 9 is deformed outwardly past its dead-center position.

The relatively greater deformability of the wall 9 as compared with thewall 10 may be achieved in various ways. For example, the wall thicknessof the former may be made slightly less than that of the latter; or thewall 9 may be provided with one or more annular corrugations (notshown). When the wall 9 is invaginated, i.e. in the collapsed conditionshown in FIG. 2, the base of the neck 7 together with the adjoining partof the wall 9 form, in effect, a plug which closes the orifice betweenthe bellows section 9, 10 and the adjoining bellows section 11.

The end surface 12 of the stud 5 is slightly concave to receive theusers thumb and the size and shape of the head 8 of the stud 5 aregenerally such as to provide a stable base for the syringe when stoodneedle upward upon a table or the like.

Suitable plastics materials for the ampoule 4 and stud 5 include nylonpolymers, polyethylene, polypropylene and surgical grades of polyvinylchloride. In some cases, anti-oxidants and/ or stabilizing agentsselected in known manner according to the nature of the fluid to beinjected may be incorporated in these materials.

In an alternative embodiment shown in FIG. 3, the end section 9', 10" ofthe ampoule bellows which is nearest to the stud 5 is of the sameoverall diameter as the remaining bellows sections 12, but is moreeasily collapsible than the latter by virtue of its smaller wallthickness. While in FIG. 3, both walls 9' and 10' of the end section areshown of reduced thickness, in a variant (not illustrated) the wallcorresponding to the wall 10' is of the same thickness as the walls ofthe sections 12 and only the wall 9' is made thinner than the latter.

FIG. 4 illustrates a prefilled ampoule similar to that embodied in thesyringe illustrated in FIG. 1, but having a removable sealing cap 14fitted over the end of its nozzle 3.

The ampoule, when it is to be used for injection purposes, is preferablypre-filled with a predetermined quantity of the fluid to be injected.The pre-filled ampoules may be packed and supplied separately from thestandard needle, in which case the nozzle 3 must be effectively sealed,for example by dip-sealing in a suitable material or by applying over ita press-fit sealing cap 14 (FIG. 4) which is subsequently removed andreplaced by the needleunit 1, 2 immediately prior to use. Alternatively,the needle may be permanently affixed to the ampoule and packed as such,in which case the needle must be effectively sealed at least at itsextremity by, for example, dip-sealing in a suitable material. This seal15 (FIG. 1) is removed immediately prior to use.

In use as a hypodermic syringe, the unit is held by the needle carrier 2and the stud is pressed in with the thumb to the position shown in FIG.2, to exclude all air from the ampoule. The needle 1 is then insertedinto the patent, after which the stud 5 is withdrawn.

This withdrawal movement will enable the user to observe whether a bloodvessel has been punctured in a manner similar to that in the case of aconventional hypodermic syringe when the plunger is slightly withdrawnafter the needle has been inserted. If blood is drawn into the syringe,it will be visible through the transparent or translucent wall of theampoule 4. In that case, if intramuscular injection is required, theneedle should be withdrawn and reinserted and the procedure repeated ata different injection site. Finally, after making sure in this mannerthat the needle has been correctly inserted, the user squeezes theampoule 4 into the fully collapsed condition by thumb pressure againstthe plug 5 so that the required dose is discharged through the needle 1into the patients body.

The syringe may be supplied to the user prefilled and with the section9, collapsed.

While it is generally advantageous to arrange for only one section ofthe ampoule bellows to be collapsible independently of the others andfor this section to be located at the end remote from the nozzle, two ormore sections may be made independently collapsible and theindependently collapsible section or sections may be located at thenozzle end or in an intermediate position along the length of thebellows.

The syringe according to this invention may be used for blood sampling.For this purpose, it is preferable for more than one bellows section tobe independently collapsible and for the nozzle on the needle-supportingend of the ampoule to be located eccentrically. Furthermore, either thesyringe may be supplied with the independently collapsible sectionsalready collapsed, or these sections could be collapsed immediatelybefore use. Then, to take a blood sample, the needle 1, from which theseal 15, if provided, has previously been removed, is inserted in a veinin the patients body. Next, the collapsed sections are pulled outcreating a negative pressure within the ampoule so that blood is drawninto the ampoule. The needle is then removed and the ampoule is finallysealed, e.g., by fittting a plastics cap such as 14 (FIG. 4) over thenozzle 3 or heat-sealing its end. The sealed ampoule containing asterile specimen of blood can now be sent to the laboratory.

The instrument can of course be similarly used for taking and storingspecimens of other body liquids under sterile conditions.

I claim:

1. An ampoule in the form of a translucent collapsible concertina-ty-pebellows closed at one end and provided at the other end with a deliveryand suction duct, said bellows comprising a plurality of bellowssections, each bellows section being defined by a pair of resilient endwalls foldably joined together along a circumferential ridge and beingfoldably joined by at least one of its two end walls to an adjoining endwall of another bellows section along a circumferential valley and oneend wall of at least one of said bellows sections having less structuralstiffness to resist axial compression than the other end wall of thesame bellows section and being collapsible under a predetermined axialcompression force from an expanded position into an inverted collapsedposition in which it lies close against said other end wall, and havingan inherent over-center bias providing yielding resistance to initialdisplacement both out of said expanded position in the direction tocollapse the bellows section of which it forms part and out of saidinverted collapsed position in the direction to expand the said bellowssection and push pull operating means on said closed end of saidbellows.

2. An ampoule according to claim 1, wherein said one end wall also hasless structural stiffness against axial deformation towards a collapsedposition than the end walls of all the-other bellows sections.

3. An ampoule according to claim 2, wherein the said one bellows sectionis of larger diameter than the other bellows sections.

4. An ampoule according to claim 2, wherein the said one end wall isthinner than any other end wall of the bellows.

5. An ampoule according to claim 3, wherein the walls of all the bellowssections are frusto-conical and wherein said operating means comprises astud.

6. An ampoule in the form of a translucent collapsible concertina-typebellows provided at one end with a mounting for a hypodermic needle,said mounting being formed with an interior duct for connecting theinterior of said bellows to the interior of said needle, and at theother end with an operating stud, said bellows including a containerportion located adjacent said ducted mounting and adapted to contain apredetermined quantity of a liquid medicament and a suction-producingportion located between said container portion and said operating studand said suction-producing portion being collapsible under an axialcompression force which is less than that required to collapse saidcontainer portion and having an inherent resilient bias yield-inglyopposing expansion thereof after being collapsed and collapse thereofafter being expanded.

7. A sypringe ampoule comprising a translucent, accordian-pleatedbellows, a push-pull operating stud provided on one end of said bellows,a mounting for a hypodermic needle provided on the other end of saidbellows and formed with a duct for the passage of fluid between saidbellows and said hypodermic needle, said bellows comprising a series ofpairs of frusto-conical walls, the walls of each pair being foldablyjoined together at their bases to form a circumferential ridge and theadjoining walls of each two successive pairs being connected at theirtruncated open ends by a foldable joint forming a circumferential valleythe wall adjoining the operating stud having less structural stiffnessto resist axial compression than any other wall of the bellows and beingdeformable with an over-dead-center action between an expanded positionand an inverted collapsed position in which it lies close against theinner surface of the other wall of the same pair.

References Cited UNITED STATES PATENTS 2,688,963 9/1914 Smith 1282162,673,561 3/1954 Peterson 12 82l6 2,717,598 9/1955 Krasno l28--2162,911,972 11/1959 Elinger 128216,

RICHARD A. GAUDET, Primary Examiner.

ROBERT E. MORGAN, Examiner.

6. AN AMPOULE IN THE FORM OF A TRANSLUCENT COLLAPSIBLE CONCERTINA-TYPEBELLOWS PROVIDED AT ONE END WITH A MOUNTING FOR HYPODEMIC NEEDLE, SAIDMOUNTING BEING FORMED WITH AN INTERIOR DUCT FOR CONNECTING THE INTERIOROF SAID BELLOWS TO THE INTERIOR OF SAID NEEDLE, AND AT THE OTHER ENDWITH AN OPERATING STUD, SAID BELLOWS INCLUDING A CONTAINER PORTIONLOCATED ADJACENT SAID DUCTED MOUNTING AND ADAPTED TO CONTAIN APREDETERMINED QUANTITY OF A LIQUID MEDICAMENT AND A SUCTION-PRODUCINGPORTION LOCATED BETWEEN SAID CONTAINER PORTION AND SAID OPERATING STUDAND SAID SUCTION-PRODUCING PORTION BEING COLLAPSIBLE UNDER AN AXIALCOMPRESSION FORCE WHICH IS LESS THAN THAT REQUIRED TO COLLAPSE SAIDCONTAINER PORTION AND HAVING AN INHERENT RESILIENT BIAS YIELDINGLYOPPOSING EXPANSION THEREOF AFTER BEING COLLAPSED AND COLLAPSE THEREOFAFTER BEING EXPANDED.